PEP Topic 
Sleep-Wake Disturbances

Pregabalin is an anticonvulsant used to relieve neuropathic pain and is used with other medications to treat certain types of seizures. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body. Pregabalin comes as a capsule to take by mouth. Pregabalin has been studied in patients with cancer as an intervention for pain and peripheral neuropathy. It has also been studied for its effect on anxiety and sleep-wake disturbances.

Effectiveness Not Established

Research Evidence Summaries

Mañas, A., Ciria, J.P., Fernández, M.C., Gonzálvez, M.L., Morillo, V., Pérez, M., . . . López-Gómez, V. (2011). Post hoc analysis of pregabalin vs. non-pregabalin treatment in patients with cancer-related neuropathic pain: Better pain relief, sleep and physical health. Clinical and Translational Oncology, 13, 656–663.

doi: 10.1007/s12094-011-0711-0

Study Purpose:

To assess whether the use of pregabalin in combined therapy provides better health outcomes in patients with cancer-related neuropathic pain

Intervention Characteristics/Basic Study Process:

This study was a post hoc analysis of data from a previous epidemiologic study of clinical prevalence and analgesic management of neuropathic pain. Patients who received pregabalin versus those who did not were compared. Analgesic management was done at the individual physician’s discretion. Patients had a baseline visit and a final visit at eight weeks. In the initial study, patients were not randomized to different treatment, and numerous other interventions for analgesia were done.

Sample Characteristics:

  • The study reported on a sample of 273 patients.
  • Mean patient age was 62 years.
  • The sample was 55.6% male and 44.4% female.
  • Breast, lung, and genitourinary cancers were most prevalent.
  • All patients were receiving radiation therapy.


  • Multisite
  • Outpatient setting
  • Spain

Phase of Care and Clinical Applications:

Patients were undergoing active antitumor treatment.

Study Design:

The study was a post hoc analysis of data from a previous epidemiologic study.

Measurement Instruments/Methods:

  • Brief Pain Inventory
  • Hospital Anxiety and Depression Scale
  • Medical Outcomes Sleep Scale
  • Short-Form Health Survey (SF-12)


The most frequent cause of neuropathic pain was the tumor itself, and cisplatin was the most frequently used chemotherapeutic agent. Fentanyl patches were used more frequently in the pregabalin group. Pain intensity improved in all patients at eight weeks, but improved more with pregabalin (change = 0, 9 points, p = 0.0084). Depression and anxiety decreased significantly in both groups. Physical component and mental component scores on the SF-12 improved in all patients, but improved more in those on pregabalin. When data were adjusted for age and sex, differences from baseline scores were less than 1. There were significant differences in groups in other medications used, numbers of analgesic interventions, and amount of radiation therapy treatment.


It is difficult to draw any firm conclusions regarding efficacy of pregabalin from this study due to the differences in multiple other variables between study groups that could also affect the outcome measures used here. Changes from baseline measures seen at eight weeks were significant, but very small, raising the question of the clinical significance of results.


  • The study had baseline sample/group differences of import.
  • The study had risk of bias due to no control group, no blinding, no random assignment, and sample characteristics.
  • There were substantial differences in treatments used, as well as disease factors between groups compared here.

Nursing Implications:

No firm conclusions can be drawn from these results due to study limitations. Findings aim to show that use of pregabalin for neuropathic pain improves symptoms and  health outcomes. Differences from baseline reported here were small, suggesting lack of meaningful differences from a clinical perspective. Results point to the need for nurses to recognize the difference between statistical and clinical significance in evaluating intervention effects.